The FDA today issued recommendations for providers considering using the Total Hip System and its implants made by Synovo.
Its recommendations also apply to patients who received certain implants used in the system after 2019. Three components — the femoral resurfacing cup, acetabular fixation cup and acetabular bearing — have been significantly modified from the devices initially cleared by the FDA, the agency’s notice said.
According to the FDA, the safety and effectiveness of the system and its components have not been established. Other names for the system include the total hip replacement system, Synovo Preserve and Endotec BP.
The FDA became aware of the modifications made to the components in 2022. Following an inspection, the agency issued a warning letter to Synovo. The letter listed several violations and instructed the company to immediately stop manufacturing the modified devices. The FDA urged the company to take prompt action and cor…